BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1870147 · Received October 12, 2010

    Report

    Report Number
    2183996-2010-02113
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 12, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED HAVING UNKNOWN ELEVATED BLOOD GLUCOSE LEVEL OFTEN. PATIENT STATED THE HIGHEST BLOOD GLUCOSE READING WAS 384 MG/DL; TOOK CORRECTION WITH PEN AND THEN CHANGED THE ACCESSORIES COMPLETELY. PATIENT BEGAN USING INFUSION DEVICE ON (B)(6) 2010. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 90-100 MG/DL. PATIENT REPORTED SHE PHONE AND MET WITH HER "FAMILY DOCTOR." TREATMENT RECEIVED WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET